Various types and configurations of prosthetic heart valves are used to replace diseased natural human heart valves. The actual shape and configuration of any particularly prosthetic heart valve is dependent to some extent upon the valve being replaced (i.e., mitral valve, tricuspid valve, aortic valve, or pulmonary valve). In general, the prosthetic heart valve designs attempt to replicate the function of the valve being replaced and thus will include valve leaflet-like structures used with either bioprosthesis or mechanical heart valves prosthesis.
The bioprostheses or “tissue valves” are generally made of a suitable animal tissue or materials (e.g., harvested porcine valve leaflets, bovine or equine pericardial leaflets, synthetic material leaflets, etc.) that may be mounted onto a stationary metal or plastic frame, referred to as a “stent”. Regardless of whether a stent is provided, bioprosthetic/synthetic heart valves are generally tubular (i.e., when the leaflets are “open”, an internal passage is defined through which fluid (e.g., blood) can flow), and include a sewing or suture ring.
Leaflets made of biological material can have naturally occurring defects including fenestrations or split on the cut edge of the leaflets. A leaflet including the defect will typically be discarded during production of the valve or the prosthetic heart valve including the defect will be discarded at some other time prior to use in a patient. Additionally, the biological material of the leaflets is penetrated with sutures to assemble the leaflets into the prosthetic heart valve. This can cause weakened points in the biological material.
In order to increase the amount of useable leaflets for prosthetic heart valves, repair of fenestrations, splits, and other defects in the leaflets is desired. Additionally, reinforcement of select areas of the valve, including along suture lines, is desirable.